BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESARA ONE

    MDR report key: 23420514 · Received October 29, 2025

    Report

    Report Number
    3003990090-2025-01592
    Event Type
    Injury
    Date Received
    October 29, 2025
    Report Date
    October 29, 2025
    Manufacturer
    CALDERA MEDICAL INC.
    Product Code
    PAH
    UDI-DI
    00890594000964
    PMA / PMN Number
    K191416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MESH EROSIONS CAN BE CAUSED BY VARIOUS FACTORS, INCLUDING THE PATIENT'S PREEXISTING CONDITIONS OR ANATOMY, SURGICAL TECHNIQUES SUCH AS EXCESSIVE TENSION OR STRETCHING OF THE MESH, AND THE PATIENT'S RESPONSES, WHICH MAY INCLUDE INFLAMMATION OR INFECTION. WITHOUT PRODUCT LOT NUMBERS OR PRODUCT RETURNS, FURTHER EVALUATION OF THE ISSUE CANNOT PROCEED. THE COMPLAINT DOES NOT SPECIFY WHETHER THE EVENT IS RELATED TO THE PRODUCT, THE SURGICAL TECHNIQUE, THE SURGEON'S EXPERIENCE, OR THE PATIENT'S ANATOMY. THIS COMPLAINT WILL BE DOCUMENTED AND MONITORED THROUGH POST-MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS NECESSARY. THIS REPORT CONSIDER AS PART OF CAPA CA25-512. THE MANUFACTURING NUMBER IS C25-2762.

    Description of Event or Problem · 0

    PER SALES REP, EROSIONS ARE HAPPENING AT THE MIDLINE. ALL PATIENTS ARE POST-MENOPAUSAL, ALL WERE PRESCRIBED VAGINAL ESTROGEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1541117 DESARA ONE MESH PAH CALDERA MEDICAL INC. 00890594000964

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other